Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

FDA approves BMS’ Repotrectinib (Augty

Bristol Myers Squibb Augtyro™ (repotrectinib) is approved for treatment of adult patients with ROS1-positive non-small

Qvents
November 17, 2023

USFDA approves Santhera’s New Molecula

Vamorolone is a synthetic corticosteroid approved by USFDA for the treatment of Duchenne Muscular Dystrophy

Qvents
October 30, 2023

FDA approves NCE Gepirone (EXXUA) for Ma

Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer), a biopharmaceutical company announced approval of Exxua™ (gepirone hydrochloride extended-release tablets)

Qvents
September 29, 2023

FDA on Friday approved Lexicon’s heart

</a> Marketing Authorisation on the request of MA holder Guidehouse Germany GmbH)

Qvents
May 31, 2023